Clinical trial

Pain Control in Elderly Hip Fracture Patients: Is Intravenous Acetaminophen Superior to Oral Administration?

Name
2016-225
Description
The primary objective is to determine if intravenous acetaminophen decreases pain scores and the amount of morphine equivalence received as compared to oral acetaminophen in patients greater than 65 years old after sustaining a hip fracture.
Trial arms
Trial start
2016-12-01
Estimated PCD
2016-12-01
Trial end
2016-12-01
Status
Terminated
Phase
Early phase I
Treatment
IV Acetaminophen
The patient will receive 1,00mg IV Acetaminophen every 8 hours until 3 doses have been received post-operatively.
Arms:
IV Acetaminophen
Other names:
Ofirmev
PO Acetaminophen
The patient will receive 1,000mg po Acetaminophen every 8 hours.
Arms:
PO Acetaminophen
Other names:
Tylenol
Size
1
Primary endpoint
Pain Score
6 days
Eligibility criteria
Inclusion Criteria: 1. Acute, isolated, unilateral femoral neck, intertrochanteric, and per trochanteric hip fractures confirmed by anteroposterior/lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI). 2. Age ≥ 65 years. 3. Low energy mechanism. 4. Hip fracture fixation performed within 48 hours of injury. 5. English speaking. 6. Anticipated medical optimization for operative fixation. 7. No other major trauma. Exclusion Criteria: 1. Unable to provide informed consent (dementia, limited decision making capacity) 2. Admitted by medical service for significant co-morbidities 3. Retained hardware around the affected hip 4. Infection around the affected hip 5. Transfer patients with a length of stay \> 24 hours at the transferring hospital 6. Known allergy to acetaminophen 7. Current use of narcotics 8. Receiving a regional anesthetic block at any point during the hospitalization 9. Known history of hepatic disease (hepatitis, cirrhosis) 10. Weight \< 50kg 11. Prisoner 12. Involved in another clinical trial that would interfere with the intervention of this study
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1, 'type': 'ACTUAL'}}
Updated at
2023-09-28

1 organization

1 product

1 indication

Indication
Hip Fracture